Apparatus and method for altering generator functions in an ultrasonic surgical system

ABSTRACT

The present invention provides a system for implementing surgical procedures which includes an ultrasonic surgical hand piece having an end-effector, a console having a digital signal processor (DSP) for controlling the hand piece, an electrical connection connecting the hand piece and the console, and a memory, such as an EEPROM (Electrically Erasable Programmable Read Only Memory), disposed in the electrical connection. The console sends a drive current to drive the hand piece which imparts ultrasonic longitudinal movement to the blade. The console reads the memory and authenticates the hand piece for use with the console if particular or proprietary data are present in the memory. Moreover, to prevent errors in operating the hand piece, the memory can store certain diagnostic information which the console can utilize in determining whether the operation of the hand piece should be handicapped or disabled. Furthermore, the memory can be used to reprogram the console, if needed.

RELATED APPLICATIONS

The present application relates to, and claims priority of, U.S.Provisional Patent Application Ser. No. 60/242,171 filed on Oct. 20,2000 and entitled EEPROM TO ENABLE/DISABLE GENERATOR FUNCTIONS IN ANULTRASONIC SURGICAL HAND PIECE, which is incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to an apparatus & method foraltering generator functions in an ultrasonic surgical system and, moreparticularly, to an ultrasonic system for providing information to agenerator from an ultrasonic surgical instrument.

2. Description of the Related Art

It is known that electric scalpels and lasers can be used as a surgicalinstrument to perform the dual function of simultaneously effecting theincision and hemostatis of soft tissue by cauterizing tissues and bloodvessels. However, such instruments employ very high temperatures toachieve coagulation, causing vaporization and fumes as well assplattering, which increases the risk of spreading infectious diseasesto operating room personnel. Additionally, the use of such instrumentsoften results in relatively wide zones of thermal tissue damage.

Cutting and cauterizing of tissue by means of surgical blades vibratedat high speeds by ultrasonic drive mechanisms is also well known. One ofthe problems associated with such ultrasonic cutting instruments isuncontrolled or undamped vibrations and the heat as well as materialfatigue resulting therefrom. In an operating room environment attemptshave been made to control this heating problem by the inclusion ofcooling systems with heat exchangers to cool the blade. In one knownsystem, for example, the ultrasonic cutting and tissue fragmentationsystem requires a cooling system augmented with a water circulatingjacket and means for irrigation and aspiration of the cutting site.Another known system requires the delivery of cryogenic fluids to thecutting blade.

It is known to limit the current delivered to the transducer as a meansfor limiting the heat generated therein. However, this could result ininsufficient power to the blade at a time when it is needed for the mosteffective treatment of the patient. U.S. Pat. No. 5,026,387 to Thomas,which is assigned to the assignee of the present application and isincorporated herein by reference, discloses a system for controlling theheat in an ultrasonic surgical cutting and hemostasis system without theuse of a coolant, by controlling the drive energy supplied to the blade.In the system according to this patent an ultrasonic generator isprovided which produces an electrical signal of a particular voltage,current and frequency, e.g. 55,500 cycles per second. The generator isconnected by a cable to a hand piece which contains piezoceramicelements forming an ultrasonic transducer. In response to a switch onthe hand piece or a foot switch connected to the generator by anothercable, the generator signal is applied to the transducer, which causes alongitudinal vibration of its elements. A structure connects thetransducer to a surgical blade, which is thus vibrated at ultrasonicfrequencies when the generator signal is applied to the transducer. Thestructure is designed to resonate at the selected frequency, thusamplifying the motion initiated by the transducer.

The signal provided to the transducer is controlled so as to providepower on demand to the transducer in response to the continuous orperiodic sensing of the loading condition (tissue contact or withdrawal)of the blade. As a result, the device goes from a low power, idle stateto a selectable high power, cutting state automatically depending onwhether the scalpel is or is not in contact with tissue. A third, highpower coagulation mode is manually selectable with automatic return toan idle power level when the blade is not in contact with tissue. Sincethe ultrasonic power is not continuously supplied to the blade, itgenerates less ambient heat, but imparts sufficient energy to the tissuefor incisions and cauterization when necessary.

The control system in the Thomas patent is of the analog type. A phaselock loop that includes a voltage controlled oscillator, a frequencydivider, a power switch, a match net and a phase detector, stabilizesthe frequency applied to the hand piece. A microprocessor controls theamount of power by sampling the frequency current and voltage applied tothe hand piece, because these parameters change with load on the blade.

The power versus load curve in a generator in a typical ultrasonicsurgical system, such as that described in the Thomas patent has twosegments. The first segment has a positive slope of increasing power, asthe load increases, which indicates constant current delivery. Thesecond segment has a negative slope of decreasing power as the loadincreases, which indicates a constant or saturated output voltage. Theregulated current for the first segment is fixed by the design of theelectronic components and the second segment voltage is limited by themaximum output voltage of the design. This arrangement is inflexiblesince the power versus load characteristics of the output of such asystem can not be optimized to various types of hand piece transducersand ultrasonic blades. The performance of traditional analog ultrasonicpower systems for surgical instruments is affected by the componenttolerances and their variability in the generator electronics due tochanges in operating temperature. In particular, temperature changes cancause wide variations in key system parameters such as frequency lockrange, drive signal level, and other system performance measures.

In order to operate an ultrasonic surgical system in an efficientmanner, during startup the frequency of the signal supplied to the handpiece transducer is swept over a range to locate the resonancefrequency. Once it is found, the generator phase lock loop locks on tothe resonance frequency, keeps monitoring of the transducer current tovoltage phase angle and maintains the transducer resonating by drivingit at the resonance frequency. A key function of such systems is tomaintain the transducer resonating across load and temperature changesthat vary the resonance frequency. However, these traditional ultrasonicdrive systems have little to no flexibility with regards to adaptivefrequency control. Such flexibility is key to the system's ability todiscriminate undesired resonances. In particular, these systems can onlysearch for resonance in one direction, i.e., with increasing ordecreasing frequencies and their search pattern is fixed. The systemcannot hop over other resonance modes or make any heuristic decisionssuch as what resonance/s to skip or lock onto and ensure delivery ofpower only when appropriate frequency lock is achieved.

The prior art ultrasonic generator systems also have little flexibilitywith regard to amplitude control, which would allow the system to employadaptive control algorithms and decision making. For example, thesefixed systems lack the ability to make heuristic decisions with regardsto the output drive, e.g., current or frequency, based on the load onthe blade and/or the current to voltage phase angle. It also limits thesystem's ability to set optimal transducer drive signal levels forconsistent efficient performance, which would increase the useful lifeof the transducer and ensure safe operating conditions for the blade.Further, the lack of control over amplitude and frequency controlreduces the system's ability to perform diagnostic tests on thetransducer/blade system and to support troubleshooting in general.

Some limited diagnostic tests performed in the past involve sending asignal to the transducer to cause the blade to move and the system to bebrought into resonance or some other vibration mode. The response of theblade is then determined by measuring the electrical signal supplied tothe transducer when the system is in one of these modes. The ultrasonicsystem described in U.S. application Ser. No. 60/693,621 and filed onOct. 20, 2000 which is incorporated herein by reference possesses theability to sweep the output drive frequency, monitor the frequencyresponse of the ultrasonic transducer and blade, extract parameters fromthis response, and use these parameters for system diagnostics. Thisfrequency sweep and response measurement mode is achieved via a digitalcore such that the output drive frequency can be stepped with highresolution, accuracy, and repeatability not existent in prior artultrasonic systems.

However, the prior art systems do not provide for authentication of theuse of the hand piece with the console. Furthermore, conductingdiagnostic and performance tests in the prior art systems is cumbersome.Reprogramming or upgrading of the console in the prior art systems isalso burdensome, since each console needs to be independently tested andupgraded. In addition, the prior art system do not allow operation ofthe console with varied driving current and output displacement,depending on the type and output ability of hand piece in operation withthe console. Therefore, there is a need in the art for an improvedsystem for implementing surgical procedures which overcomes these andother disadvantages in the prior art.

SUMMARY OF THE INVENTION

The present invention provides a system for implementing surgicalprocedures which includes an ultrasonic surgical hand piece having anend-effector, a console having a digital signal processor (DSP) forcontrolling the hand piece, an electrical connection connecting the handpiece and the console, and a memory device such as an EEPROM(Electrically Erasable Programmable Read Only Memory) disposed in theelectrical connection or the hand piece. Data, in the form of a datastring which identifies the hand piece and generator performancecharacteristics, is stored in the memory device. During initializationof the system, the console sends an interrogation signal to the handpiece to obtain a readout of the memory. As the console reads thememory, the hand piece is authenticated for use with the console if theproper data is present. The hand piece is not authenticated for use withthe console if the data is not present or is not correct. In aparticular embodiment of the invention, the data is an encrypted code,where the hand piece is authenticated for use with the console bydecoding a corresponding encryption algorithm resident in the consoleand providing a responding data pattern.

Moreover, to prevent errors in operating the hand piece, the memory canstore certain diagnostic information which the console can utilize indetermining whether the operation of the hand piece should behandicapped or disabled. For instance, the memory can store informationsuch as limits on the time that the hand piece is active, the number ofactivations within a time period, the number of defective blades used,operating temperature, and other limits. Those limits stored in thememory can be re-initialized accordingly based on various operationalconditions of the hand piece.

The memory can also be used to reprogram or upgrade the console, ifneeded. For example, new hand pieces are issued periodically as newsystem functionality is achieved. When such a new hand piece isconnected, the system perform diagnostic tests to determine whether areprogram or upgrade of the console is needed. If it is determined thata reprogram or upgrade is needed, the console reads the memory locatedin the electrical connection or hand piece where a reprogram or upgradecode is stored. Using the reprogram or upgrade code read from thememory, the console is reprogrammed or upgraded accordingly. Therefore,the consoles in the field can be upgraded automatically without havingto return them to the manufacturer or to send a service technician tothe console. In a particular embodiment, the memory is a non-volatilememory can be plugged into the electrical connection or hand piece.

The memory can also store energy level information and correspondingoutput displacement for driving the particular hand piece. By readingthe energy level information, the console can drive the hand pieceaccording to the output displacement which is best for that hand piece.

In addition, the memory can store frequency sweep information includingthe nominal resonant frequency, and start and stop sweep points foreffecting a frequency sweep. Upon reading of the frequency sweepinformation stored in the memory, the console effects a frequency sweepin the indicated frequency range for detecting a resonant frequency foroperating the hand piece.

In accordance with the invention, a method is provided for implementingprocedures in a system including an ultrasonic surgical hand piecehaving an end-effector, a console having a digital signal processor(DSP) for controlling the hand piece, an electrical connectionconnecting the hand piece and the console, and a memory disposed in theelectrical connection or hand piece. The method according to theinvention includes reading information stored in the memory, determiningwhether particular or proprietary data are present in the memory,authenticating use of the hand piece with the console if the proprietarydata are present, sending a drive current to drive the hand piece, andimparting ultrasonic movement to the end-effector of the hand pieceaccording to information in the memory. In a particular embodiment, themethod according to the invention also includes decoding an encryptionalgorithm in the console, and providing a responding data pattern, wherethe data is an encrypted code.

In a further embodiment, the method according to the invention includesinstructing the hand piece to operate in a handicap mode if thetemperature of the hand piece exceeds a handicap limit, and disablingthe hand piece if the temperature of the hand piece exceeds a disablelimit. The method according to the invention can also includeinstructing the hand piece to operate in a handicap mode if the numberof defective blades found in a time period of operating the hand pieceexceeds a handicap limit, and disabling the hand piece if the number ofdefective blades found in the time period exceeds a disable limit. Themethod according to the invention can further include instructing thehand piece to operate in a handicap mode if the time the hand piece hasbeen active exceeds a handicap limit, and disabling the hand piece ifthe number of defective blades found in the time the hand piece has beenactive exceeds a disable limit. The method according to the inventioncan include further steps of operating the hand piece in a handicap modeif the number of activations for the hand piece, and/or the number ofactivations within a time period, exceed a handicap limit, and disablingthe hand piece if the number of activations for the hand piece withinthe time period exceeds a disable limit. The handicap and disable limitsstored in the memory can be re-initialized based on varied operationalconditions of the hand piece.

In an additional embodiment, the method according to the invention alsoincludes determining whether a reprogramming or upgrade of the consoleis needed, reading a reprogram or upgrade code stored in the memory andreprogramming the console using the reprogram or upgrade code, if it isdetermined that a reprogram or upgrade of the console is needed.

Moreover, the method according to another embodiment of the inventionfurther includes reading energy level information stored in the memory,and driving the hand piece according to a corresponding outputdisplacement, where the energy level information stored in the memory iscorrelated with corresponding output displacement for driving theparticular hand piece. In yet another embodiment, the method accordingto the invention also includes reading a nominal resonant frequency, astart sweep point and a stop sweep point delimiting a frequency rangefrom the memory, effecting a frequency sweep in the frequency range, anddetecting a resonant frequency for operating the hand piece.Alternatively, the frequency range information stored in the memory canbe a nominal resonant frequency, a bias amount and a margin amount,where the frequency range for the frequency sweep is calculated based onthe nominal resonant frequency, the bias amount and the margin amount.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other advantages and features of the invention willbecome more apparent from the detailed description of the preferredembodiments of the invention given below with reference to theaccompanying drawings in which:

FIG. 1 is an illustration of a console for an ultrasonic surgicalcutting and hemostasis system, as well as a hand piece and foot switchin which the method of the present invention is implemented;

FIG. 2 is a schematic view of a cross section through the ultrasonicscalpel hand piece of the system of FIG. 1;

FIGS. 3A and 3B are block diagrams illustrating the system for the handpiece according to an embodiment of the present invention;

FIG. 4 is a diagram illustrating the electrical connection between thegenerator console and the ultrasonic surgical hand piece according tothe invention in further detail;

FIG. 5 is a flow diagram illustrating the operation of the non-volatilememory according to the invention as proprietary lockout for preventinginappropriate use of the ultrasonic surgical hand piece;

FIG. 6 and FIG. 7 are flow diagrams illustrating the operation of thenon-volatile memory according to the invention for error prevention whenusing the ultrasonic surgical hand piece;

FIG. 8 is a flow diagram illustrating the operation of the non-volatilememory according to the invention for reprogramming or upgrading theconsole using the hand piece;

FIG. 9 is a flow diagram illustrating the operation of the ultrasonicsurgical hand piece at a resonant frequency using information stored inthe memory according to the invention; and

FIG. 10 is a diagram illustrating an alternative embodiment of theoperation of the hand piece at a resonant frequency using informationstored in the non-volatile memory according to the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is an illustration of a system for implementing surgicalprocedures according to the invention. By means of a first set of wiresin cable 20, electrical energy, i.e., drive current, is send from theconsole 10 to a hand piece 30 where it imparts ultrasonic longitudinalmovement to a surgical device, such as a sharp end-effector 32. Thisblade can be used for generally simultaneous dissection andcauterization of tissue. The generator in console 10 drives the handpiece 30 such that the ultrasonically tuned blade 32 mounted on theproximal end thereof vibrates and in turn is used for cutting andcoagulation in open or laparoscopic surgical procedures. The hand piece30 is a hand-held device that includes an ultrasonic resonator ortransducer that converts the appropriate electrical signals supplied bythe generator in console 10 into mechanical vibrations for vibrating thefrequency-tuned blade 32. The supply of ultrasonic current to the handpiece 30 may be under the control of a switch 34 located on the handpiece 30, which is connected to the generator in console 10 by a wire incable 26 via the electrical connection 19. The generator may also becontrolled by a foot switch 40, which is connected to the console 10 byanother cable 50. Thus, in use a surgeon may apply an ultrasonicelectrical signal to the hand piece 30, causing the blade to vibratelongitudinally at an ultrasonic frequency, by operating the switch 34 onthe hand with his finger which is activated by pressing button 18, or byoperating the foot switch 40 with his foot.

In a specific embodiment according to the invention, the button 18 is aset of twin rocker switches which are generally 180 degrees apart fromeach other. Each rocker switch in the button set 18 can signal to thegenerator console 10 for delivering power to the transducer in the handpiece 30 at a minium or maximum power levels. In addition, the footswitch 40 includes two paddles of the press-and-hold activation type,where the paddle on the left serves as the switch for activating powerdelivery at a minimum level, and the paddle on the right serves as theswitch for activating power delivery at a maximum level.

The generator console 10 includes a liquid crystal display device 12,which can be used for indicating the selected cutting power level invarious means such as percentage of maximum cutting power or numericalpower levels associated with cutting power. The liquid crystal displaydevice 12 can also be utilized to display other parameters of thesystem. A power switch 11 and power “on” indicator 13 are also providedon the console. Further, buttons and switches 16 to 17 control variousother functions of the system may be located on the console front panel.

When power is applied to the ultrasonic hand piece by operation ofeither switch 34 or 40, the assembly will cause the surgical scalpel orblade to vibrate longitudinally at approximately 55.5 kHz, and theamount of longitudinal movement will vary proportionately with theamount of driving power (current) applied, as adjustably selected by theuser. When relatively high cutting power is applied, the blade isdesigned to move longitudinally in the range of about 40 to 100 micronsat the ultrasonic vibrational rate. Such ultrasonic vibration of theblade will generate heat as the blade contacts tissue, i.e., theacceleration of the blade through the tissue converts the mechanicalenergy of the moving blade to thermal energy in a very narrow andlocalized area. This localized heat creates a narrow zone ofcoagulation, which will reduce or eliminate bleeding in small vessels,such as those less than one millimeter in diameter. The cuttingefficiency of the blade, as well as the degree of hemostasis, will varywith the level of driving power applied, the cutting rate or forceapplied by the surgeon to the blade, the nature of the tissue type, andthe vascularity of the tissue.

As illustrated in more detail in FIG. 2, the ultrasonic hand piece 30houses a piezoelectric transducer 36 for converting electrical energy tomechanical energy that results in longitudinal vibrational motion of theends of the transducer. The transducer 36 is in the form of a stack ofceramic piezoelectric elements having a motion null point at the centerof the stack. It is mounted between two cylinders 31 and 33. Inaddition, a cylinder 35 is attached to cylinder 33, which is mounted tothe housing at another motion null point 37. A horn 38 is also attachedto the null point on one side and to a coupler 39 on the other side.Blade 32 is fixed to the coupler 39. As a result, the blade 32 willvibrate in the longitudinal direction at an ultrasonic frequency ratewith the transducer 36. The ends of the transducer achieve maximummotion, with the center of the stack constituting a motionless node,when the transducer is driven at maximum current at the transducer'sresonant frequency.

The parts of the hand piece are designed such that the combination willoscillate at generally the same resonant frequency. In particular, theelements are tuned such that the resulting length of each such elementis one-half wavelength. Longitudinal back and forth motion is amplifiedas the diameter closer to the blade 32 of the acoustical mounting horn38 decreases. Thus the horn 38 as well as the blade/coupler are shapedand dimensioned so as to amplify blade motion and provide harmonicvibration in resonance with the rest of the acoustic system, whichproduces the maximum back and forth motion of the end of the acousticalmounting horn 38 close to the blade 32, preferably from 20 to 25microns.

The system which creates the ultrasonic electrical signal for drivingthe transducer in the hand piece is illustrated in FIG. 3A and FIG. 3B.This drive system is flexible and can create a drive signal at a desiredfrequency and power level setting. A DSP 60 or microprocessor in thesystem is used for monitoring the appropriate power parameters andvibratory frequency as well as causing the appropriate power level to beprovided in either the cutting or coagulation operating modes. The DSP60 or microprocessor also stores computer programs which are used toperform diagnostic tests on components of the system, such as thetransducer/blade.

For example, under the control of a program stored in the DSP ormicroprocessor 60, such as a phase correction algorithm, the frequencyduring startup can be set to a particular value, e.g., 50 kHz. It canthan be caused to sweep up at a particular rate until a change inimpedance, indicating the approach to resonance, is detected. Then thesweep rate can be reduced so that the system does not overshoot theresonance frequency, e.g., 55 kHz. The sweep rate can be achieved byhaving the frequency change in increments, e.g., 50 cycles. If a slowerrate is desired, the program can decrease the increment, e.g., to 25cycles which both can be based adaptively on the measured transducerimpedance magnitude and phase. Of course, a faster rate can be achievedby increasing the size of the increment. Further, the rate of sweep canbe changed by changing the rate at which the frequency increment isupdated.

If it is known that there is an undesired resonant mode , e.g., at say51 kHz, the program can cause the frequency to sweep down, e.g., from 60kHz, to find resonance. Also, the system can sweep up from 50 kHz andhop over 51 kHz where the undesired resonance is located. In any event,the system has a great degree of flexibility

In operation, the user sets a particular power level to be used with thesurgical instrument. This is done with power level selection switch 16on the front panel of the console. The switch generates signals 150 thatare applied to the DSP 60. The DSP 60 then displays the selected powerlevel by sending a signal on line 152 (FIG. 3B) to the console frontpanel display 12.

To actually cause the surgical blade to vibrate, the user activates thefoot switch 40 or the hand piece switch 34. This activation puts asignal on line 154 in FIG. 3A. This signal is generally effective tocause power to be delivered from push-pull amplifier 78 to thetransducer 36. When the DSP or microprocessor 60 has achieved lock onthe hand piece transducer resonance frequency and power has beensuccessfully applied to the hand piece transducer, an audio drive signalis put on line 156. This causes an audio indication in the system tosound, which communicates to the user that power is being delivered tothe hand piece and that the scalpel is active and operational.

As described herein with respect to FIG. 2, FIG. 3A and FIG. 3B and inthe related U.S. application Ser. No. 09/693,621 and incorporated hereinby reference, the parts of the hand piece 30 in operational mode aredesigned, as a whole, to oscillate at generally the same resonantfrequency, where the elements of the hand piece 30 are tuned so that theresulting length of each such element is one-half wavelength or amultiple thereof. Microprocessor or DSP 60, using a phase correctionalgorithm, controls the frequency at which the parts of the hand piece30 oscillate. Upon activation of the hand piece 30, the oscillatingfrequency is set at a startup value or nominal resonant frequency suchas 50 kHz which is stored in memory. A sweep of a frequency rangebetween a start sweep point and a stop sweep point is effected under thecontrol of the DSP 60 until the detection of a change in impedance whichindicates the approach to the resonant frequency. The change inimpedance refers to the impedance of the hand piece and its transducers,which may be modeled by a parallel equivalent circuit for mathematicallymodeling the algorithm for controlling the operation of the hand piece30 as described in the related U.S. application Ser. No. 09/693,621. Theresonant frequency is the frequency at a point during the frequencysweep where the impedance of the equivalent circuit is at its minimumand the anti-resonant frequency is the frequency where the impedance ismaximum. Phase margin is the difference between the resonant frequencyand an anti-resonant frequency. A correlation between the phase marginand the output displacement of the hand piece 30 exists which canadvantageously be used to control the displacement so that the handpiece 30 operates at its optimal performance level.

In order to obtain the impedance measurements and phase measurements,the DSP 60 and the other circuit elements of FIG. 3A and 3B are used. Inparticular, push-pull amplifier 78 delivers the ultrasonic signal to apower transformer 86, which in turn delivers the signal over a line 85in cable 26 to the piezoelectric transducers 36 in the hand piece. Thecurrent in line 85 and the voltage on that line are detected by currentsense circuit 88 and voltage sense circuit 92. The current and voltagesense signals are sent to average voltage circuit 122 and averagecurrent circuit 120, respectively, which take the average values ofthese signals. The average voltage is converted by analog-to-digitalconverter (ADC) 126 into a digital code that is input to DSP 60.Likewise, the current average signal is converted by analog-to-digitalconverter (ADC) 124 into a digital code that is input to DSP 60. In theDSP the ratio of voltage to current is calculated on an ongoing basis togive the present impedance values as the frequency is changed. Asignificant change in impedance occurs as resonance is approached.

The signals from current sense 88 and voltage sense 92 are also appliedto respective zero crossing detectors 100, 102. These produce a pulsewhenever the respective signals cross zero. The pulse from detector 100is applied to phase detection logic 104, which can include a counterthat is started by that signal. The pulse from detector 102 is likewiseapplied to logic circuit 104 and can be used to stop the counter. As aresult, the count which is reached by the counter is a digital code online 140, which represents the difference in phase between the currentand voltage. The size of this phase difference is also an indication ofhow close the system is operating to the resonant frequency. Thesesignals can be used as part of a phase lock loop that cause thegenerator frequency to lock onto resonance, e.g., by comparing the phasedelta to a phase set point in the DSP in order to generate a frequencysignal to a direct digital synthesis (DDS) circuit 128 that drives thepush-pull amplifier 78.

Further, the impedance and phase values can be used as indicated abovein a diagnosis phase of operation to detect if the blade is loose. Insuch a case the DSP does not seek to establish phase lock at resonance,but rather drives the hand piece at particular frequencies and measuresthe impedance and phase to determine if the blade is tight.

FIG. 4 is a diagram that illustrates the electrical connection 19between the console and the hand piece 30 in further detail. Accordingto a specific embodiment of the invention, the electrical connection 19,which can be a serial or parallel connection, is a male-femaleelectrical connection set. It includes, on one end leading to the handpiece 30 via the cable 26, an electrical connector 19B with pins 401,402, 403, 404, 405, 406 and 407, and on the other end a correspondingconnector 19A leading to the console 10 and having receptacles 401A,402A, 403A, 404A, 405A, 406A and 407A. These receptacles respectivelyreceive pins 401, 402, 403, 404, 405, 406 and 407 of connector 19B. Forengaging or disengaging the electrical connection 19, the connectors 19Aand 19B only require simple act of connecting them by human hands, andneed no additional tooling to engage or disengage them. The electricalconnector 19B includes a memory 400 which is a non-volatile memorydevice that retains its data for subsequent usage even if power isremoved therefrom, such as an electrically erasable programmable readonly memory or EEPROM. The memory 400 is connected to pin 405 fortransferring data to and from the console 10 at a direct current (DC) ofgenerally 10 mA (milli-amperes).

With respect to the other pins, pin 401 is for delivering the“transducer high” signal for operating the transducer 36 in the handpiece 30 at a high power level, using an alternating current (AC) ofgenerally 1 A (ampere). Pin 402 is for delivering the “transducer low”signal for operating the transducer 36 in the hand piece 30 at a lowpower level, also using an alternating current (AC) of generally 1 A.Pins 403 and 404 are for delivering hand-activation signals (e.g., bypressing button 18) to the hand piece 30, at an alternating current (AC)of generally 10 mA. Pin 406 is for delivering a general or common signalto the memory 400, at a direct current (DC) of generally 10 mA. Pin 407is for delivering a signal which indicates the presence (or lackthereof) of the hand piece 30, also at a direct current (DC) ofgenerally 10 mA.

The memory 400 is advantageously provided in the electrical connector19B for reducing unneeded complexity in electrical isolationconfigurations which contribute to increases in costs, complications incross-talk noise issues, and adversely affects the ergonomic performanceof the hand piece 30. By placing the memory 400 in the electricalconnector 19B, with adequate electrical isolation of the memory 400circuitry, the human operator thereof, and the patient is readilyachieved. Also, the number of wires in cable 26 can be reduced. However,if desired, the memory 400 can be located in the hand piece 30, but thisis not preferred.

FIG. 5 is a flow diagram that illustrates the operation of the memory400 as a proprietary lockout for preventing inappropriate use of thehand piece 30. The memory 400 can be utilized to prevent unauthorized,unintentional or inadvertent use of the hand piece 30 with the console10. Inappropriate usage includes hazardous use, poor operational usage,or non-compatible use with the console 10.

In step 501, the hand piece 30 is activated, e.g., by pressing thebutton 18 on console 10for hand-activation-enable of the hand piece 30.In step 503, console 10 then reads the memory 400 by accessing it viapin 405 in the electrical connection 19 at its mated position. In step505, it is determined whether proprietary data (in the form of a datastring) is present in the memory 400. The proprietary data, input intothe non-volatile memory for all authorized hand pieces, are in digitalor analog form. The proprietary data can also be a musical, speech, orsound effect in either digital or analog format. Having a properproprietary data string in the memory 400 means that the use of the handpiece with console 10 is authorized or authenticated. The proprietarydata can be copyrighted to protect against unlawful or unauthorized useof the hand piece. If the proprietary data are present in the memory400, the hand piece 30 is enabled or activated by console 10 (step 507).If the proprietary data are not present in the memory 400 or an improperdata string is present, the hand piece 30 is not enabled (step 509), andan error message appears on the display device 12 at the console 10indicating unauthorized use.

In a specific embodiment according to the invention, when the console 10reads the data in the memory 400, a cyclical redundancy check (CRC) isused to detect read errors and/or to authenticate the hand piece. A CRCis a mathematical method that permits errors in long runs of data to bedetected with a very high degree of accuracy. Before data is transmittedover a phone, for example, the sender can compute a 32-bit CRC valuefrom the data's contents. If the receiver computes a different CRCvalue, then the data was corrupted during transmission. Matching CRCvalues confirms with near certainty that the data was transmittedintact.

According to the CRC authentication technique, the entire block of datais treated as a long binary number which is divided by a convenientlysmall number and the remainder is used as the check value that is tackedonto the end of the data block. Choosing a prime number as the divisorprovides excellent error detection. The number representing the completeblock (main data plus CRC value) is always a multiple of the originaldivisor, so using the same divisor always results in a new remainder ofzero. This means that the same division process can be used to checkincoming data as is used to generate the CRC value for outgoing data. Atthe transmitter, the remainder is (usually) non-zero and is sentimmediately after the real data. At the receiver, the entire data blockis checked and if the remainder is zero, then the data transmission isconfirmed.

An 8-bit CRC generator can be implemented in hardware, software orfirmware in the memory 400. Firmware is the controller software for ahardware device, which can be written or programmed in a non-volatilememory (e.g., memory 400) such as an EEPROM or flash ROM (read onlymemory). The firmware can be updated with a flash program for detectionand correction of bugs in the controller software or to improveperformance of the hardware device. An exemplary EEPROM used inimplementing the invention is the 256-bit DS2430A 1 wire deviceorganized as one page of 32 bytes for random access with a 64-bitone-time programmable application register, which is a part of theIBUTTON™ family of hardware devices commercially available from DALLASSEMICONDUCTOR™.

The following exemplary software code in “C” which is a commonly usedprogramming language in the art, illustrates how the 8-bit CRC iscalculated when reading the data in the memory 400 for authenticatinguse of the hand piece with console 10. Prior to the calculation of theCRC of a block of data, the 8-bit CRC is first initialized to zero. Whenconsole reads the 8 bytes of the data in the memory 400, an 8-bit CRC iscalculated for each of the 8 bytes of the data. If the resultant 8-bitCRC is equal to zero, then the use of the hand piece is with console 10is authenticated, and the hand piece is enabled. If the resultant 8-bitCRC is not equal to zero, then the use of the hand piece with console 10is not authenticated, the hand piece not enabled, and an error messageappears on the display device 12 at console 10 indicating unauthorizeduse. /* ============================================= FUNCTION  mlan_CRC8 PASSED PARAMETERS   ‘data’ - data byte to calculate the 8bit crc from   ‘crc8’ - the current CRC. RETURN   the updated 8 bit CRC.============================================= /* static uchar crc_table[] = {  0, 94, 188,226, 97, 63,221, 131, 194,156,126, 32,163,253, 31, 65 157,195, 33,127,252,162, 64, 30, 95, 1,227, 189, 62, 96,130,220, 190,224, 2, 92,223,129, 99, 61,124, 34, 192,158, 29, 67,161,255,  70,24,250,164, 39,121,155,197,132,218 56,102,229,187, 89, 7, 219,133,103,57,186,228, 6, 88, 25, 71, 165,251,120, 38,196,154,  101,59,217,135, 4, 90,184,230,167,249, 27, 69,198,152,122,36,  248,166, 68,26,153,199, 37,123, 58,100,134,216, 91, 5,231,185  140,210,48,110,237,179, 81, 15, 78, 16,242,172, 47,113,147,205,  17,79,173,243,112, 46,204,146,211, 141,111, 49,178,236, 14, 80,  175,241,19, 77,206,144,114, 44,109, 51,209,143, 12, 82,176,238,  50,108,142,208,83, 13,239,177,240,174, 76, 18,145,207, 45,115,  202,148,118,40,171,245, 23, 73, 8, 86,180,234,105, 55,213,139,  87, 9,235,181,54,104,138,212,149,203, 41,119,244,170, 72, 22,  233,183, 85,11,136,214, 52,106, 43,117,151,201, 74, 20,246,168,  116, 42,200,150,21, 75,169,247,182,232, 10, 84,215,137,107,53 }; uchar mlan_CRC8(uchardata, uchar crc8) {  return crc_table[crc8 {circumflex over ( )} data];}

Another exemplary software code is listed below for calculating a 16-bitCRC for the memory 400. Similarly, prior to the calculation of the CRCof a block of data, the 16-bit CRC is first initialized to zero. Whenconsole 10 reads the 16 bytes of the data in the memory 400, a 16-bitCRC is calculated for each of bytes 1 through 30 of the data, and theresults are stored in bytes 31 and 32. After comparing the results, ifthe resultant CRC is equal to zero, then the use of the hand piece withconsole 10 is authenticated, and the hand piece is enabled. If theresultant CRC is not equal to zero, then the use of the hand piece withconsole 10 is not authenticated, the hand piece is not enabled, and anerror message appears on the display device 12 at console 10 indicatingunauthorized use. /* =============================================FUNCTION   mlan_CRC16 PASSED PARAMETERS   ‘data’ - current word to addinto the CRC   ‘crc16’ - the current value of the 16 bit CRC RETURN  new value of the 16 bit CRC=============================================/* static int oddparity[16]= {0, 1, 1, 0, 1, 0, 0, 1, 1, 0, 0, 1, 0, 1, 1, 0}; uint mlan-CRC16(uintdata, uint crc16) {  data = (data {circumflex over ( )} (crc16 & 0xff))& 0xff;  crc16>>=8; if (oddparity[data & 0xf] {circumflex over ( )}oddparity[data >> 4])  crc16 {circumflex over ( )} =0xc001; data <<=6;crc16 {circumflex over ( )}= data; data <<= 1; crc16 {circumflex over( )}= data; return crc16; }

Furthermore, the data in the memory 400 can be an encrypted code which,when decoded by a corresponding encryption algorithm resident at console10, provides a corresponding data pattern that serves to authenticateproper usage of the hand piece with the console. Encryption is achievedwith algorithms that use a computer “key” to encrypt and decryptmessages by turning text or other data into an unrecognizable digitalform and then by restoring it to its original form. The longer the“key,” the more computing is required to crack the code. To decipher anencrypted message by brute force, one would need to try every possiblekey. Computer keys are made of “bits” of information of various length.For instance, an 8-bit key has 256 (2 to the eighth power) possiblevalues. A 56-bit key creates 72 quadrillion possible combinations. Ifthe key is 128 bits long, or the equivalent of a 16-character message ona personal computer, a brute-force attack would be 4.7 sextillion(4,700,000,000,000,000,000,000) times more difficult than cracking a56-bit key. With encryption, unauthorized use of the hand piece withconsole 10 is generally prevented, with a rare possibility of theencrypted code being deciphered for unauthenticated use.

A unique identification (ID) number is registered and stored in thememory (e.g., memory 400) for every hand piece manufactured which iscompatible for use with console 10. In a specific embodiment accordingto the invention, the memory 400 is the DS2430A 1 wire EEPROM device,commercially available from DALLAS SEMICONDUCTOR™, which stores afactory-lasered and tested 64-bit ID number for each hand piecemanufactured. The ID number can be a model or model family number, inaddition to being a unique serial number ID for each individual handpiece. This allows the generator console 10 to acknowlege itscompatibility and useability therewith, without requiring a list ofserial numbers for that model or model family. Foundry lock data in ahardware format and protocol is stored in the memory 400 to ensurecompatibility with other products of generally the same communicationsprotocol, e.g., the products of the MICROLAN™ protocol commerciallyavailable from DALLAS SEMICONDUCTOR™ . This advantageously providesscalability for providing a system with additional surgical devices on alocal area network (LAN) operating on generally the same communicationsprotocol.

FIG. 6 and FIG. 7 are flow diagrams that illustrate the operation of thememory 400 according to the invention for error prevention when usingthe hand piece 30 with console 10. To prevent errors in operating thehand piece 30, the memory 400 can store certain diagnostic informationwhich console 10 can utilize in determining whether the operation of thehand piece 30 should be handicapped or disabled. For instance, thememory 400 can store information such as limits on the time that thehand piece is active, the number of activations within a time period,the number of defective blades used, temperature, and any otherperformance characteristics such as, for example, those listed inTable 1. Those skilled in the art can appreciate that other errorprevention, diagnostic and performance characteristics can be stored inmemory 400. Exemplary performance characteristics that can be stored inmemory 400 (as shown in Table 1) include surgical device typeinformation and revision data (row 1 in Table 1), current set point (row2), transducer capacitance (row 3), cable capacitance (row 4), phasemargin for the hand piece equipped with a test tip or end-effector (row5), resonant frequency (row 6), remaining operating procedures (row 7),lower bound or threshold on operating frequency (row 8), upper bound orthreshold on operating frequency (row 9), maximum output power (row 10),power control information and authorization (row 11), hand pieceimpedance (row 12), total on-time information at specific power levels(rows 13 and 14), hand piece enable/disable diagnostic information (row15), hand piece error codes (row 16), temperature range and change data(rows 17, 18 and 19), current excess load limit (row 20), high impedancefault limit (row 21), and cyclical redundancy check (CRC) data (row 22).

Moreover, the memory 400 can store user-specific data such as username,internal tracking number, calibration schedule, and custom outputperformance. The user-specific data can be manipulated or programmedthrough the generator console 10 or initialized at the time the handpiece 30 is made at the factory. TABLE 1  1 Bits 1-3. Device Type Bits4-8: Revision  2 Current set point I_(setpoint)  3 TransducerCapacitance C_(o)  4 Cable Capacitance C_(c)  5 Phase margin with testtip Pm₀  6 Resonance frequency f_(ro)  7 Allowed Procedures Remaining  8Lower bound on seek/lock frequency (offset from f_(ro)) f_(lower bound) 9 Upper bound on seek/lock frequency (offset from f_(ro))f_(upper bound) 10 Maximum output power @ level 5 W_(max) 11 Bit 1Backside power curve control variable: Capped Power = 1; Descendingpower = 0 Bit 2; Single cap at all levels = 1, Different cap for eachpower level = 0 Bit 3: Hand piece Authorized Activation Flag. Bits 4-8:Unused 12 Hand piece Impedance, Re |Z| 13 Total On-Time @ level 5 14Total on-Time @ level <5 15 Hand piece Diagnostics Enable/Disable Flagsbyte no. 1 Hand piece Diagnostics Enable/Disable Flags byte no. 2 16Hand piece error code 1 (newest) Hand piece error code 2 Hand pieceerror code 3 Hand piece error code 4 Hand piece error code 5 (oldest) 17ΔC_(o) Over Temp Entry 18 ΔC_(o) Over Temp Exit 19 C_(o)Max Rate ofChange 20 Current Excessive Load Limit 21 High Impedance with test tipfault limit 22 Data CRC

According to a specific embodiment of the invention, once the hand piece30 is activated for use, console 10 reads the memory 400 (step 601) forthe diagnostic information. In step 603, console 10 determines whetherthe temperature of the hand piece 30 is over the handicap limit storedin the memory 400. If so, console 10 then instructs the hand piece 30 tooperate in the handicap mode (step 605), e.g., operating below a certainspeed or vibrational frequency or in a limited mode such as coagulationor cutting in order to avoid overheating, or in a non-limited mode witha specific vibrational annunciation. If not, the flow control goes tostep 607, where console 10 determines whether the temperature of thehand piece 30 is over the disable limit stored in the memory 400. If so,console 10 disables the hand piece 30 (step 609). If not, the flowcontrol goes to step 611, where console 10 determines whether the numberof defective blades found within a time period of operating the handpiece 30 has exceeded the handicap limit stored in the memory 400. Ifso, console 10 then instructs the hand piece 30 to operate in thehandicap mode (step 613), e.g., operating below a certain speed orvibrational frequency below the nominal vibrational displacement, or ina limited mode such as coagulation or cutting in order to decrease theincidences of blades 32 becoming defective. The handicap mode in step613 is not necessarily the same as the handicap mode in step 605,depending on the optimal mode for operating the hand piece 30 under thecircumstances with respect to steps 603 and 611.

If the number of defective blades found has not exceeded the handicaplimit, the flow control is directed to step 615, where console 10determines whether the number of defective blades found within a timeperiod has exceeded the disable limit stored in the memory 400. If so,console 10 disables the hand piece 30 (step 609). If not, the controlflow is directed, via step A, to step 617, where console 10 determineswhether the time the hand piece 30 has been active has exceeded thehandicap limit stored in memory 400. If so, console 10 instructs thehand piece 30 to operate in a handicap mode, e.g., operating below acertain speed or vibrational frequency, below the nominal vibrationaldisplacement, or in a limited mode such as coagulation or cutting. Thehandicap mode in step 619 is not necessarily the same as the handicapmode in steps 605 or 613, depending on the optimal mode for operatingthe hand piece 30 under the circumstances with respect to steps 603, 611and 617.

If the time the hand piece 30 has been active has not exceeded thehandicap limit, the flow control is directed to step 621, where console10 determines whether the time the hand piece has been active hasexceeded the disable limit stored in the memory 400. If so, the controlflow is directed, via step B, to step 609 where console 10 disables thehand piece 30. If not, the control flow goes to step 623, where console10 determines whether the number of activations for the hand piece 30within a time period has exceeded the handicap limit stored in memory400. If so, console 10 instructs the hand piece 30 to operate in ahandicap mode (step 625), e.g., operating below a certain speed orvibrational frequency, below the nominal vibrational displacement, or ina limited mode such as coagulation or cutting. The handicap mode in step625 is not necessarily the same as the handicap mode in steps 605, 613or 619, depending on the optimal mode for operating the hand piece 30under the circumstances with respect to steps 603, 611, 617 and 623.

If the number of activations for the hand piece 30 within a time periodhas not exceeded the handicap limit, the flow control is directed tostep 627, where console 10 determines whether the number of activationsfor the hand piece 30 within a time period has exceeded the disablelimit stored in the memory 400. If so, the control flow is directed, viastep B, to step 609 where console 10 disables the hand piece 30. If not,the control flow is directed, via step C, to step 601 from which theprocess steps according to this particular embodiment of the inventionmay be repeated upon subsequent users until the hand piece 30 is causedto be disabled.

The disable limits and the handicap limits described herein with respectto FIG. 6 and FIG. 7 may be of substantively different criteria forconsole 10 to determine the operational mode of the hand piece 30. Thememory 400 may be re-initialized for different disable or handicaplimits for varied operational conditions of the hand piece 30. Console10 may likewise be re-initialized to operate on varied criteria forcontrolling the operational mode of the hand piece 30 based on theinformation stored in the memory 400.

In addition to the disable and handicap modes of operation, an alarm oralert mode can further be provided when certain criteria are met toalert and allow a human operator of the hand piece to take appropriateaction to remedy the alerted operating condition.

FIG. 8 is a flow diagram that illustrates the operation of the memory400 according to the invention for reprogramming or upgrading console 10using the hand piece 30. In step 801, console 10 performs diagnostictests on the functions of the console. It is determined in step 803whether any functions are deemed inadequate, e.g., functions that needto be altered, disabled or added. For example, the error preventionfunctions described herein with respect to FIG. 6 and FIG. 7 may need tobe added, or the handicap limits and operational modes may need to bere-initialized. If it is determined that certain functions areinadequate, the flow control is directed to step 807. In step 807,console 10 reads the memory 400 of the hand piece 30 where the reprogramcode has been stored in step 800. Using the reprogram code read from thememory 400, the functions of console 10 are reprogrammed.

If it is determined in step 803 that the functions of console 10 areadequate or the memory has a newer version of the program, then theconsole 10 has, the flow control directed to step 805. It is determinedin step 805 whether an upgrade is needed for console 10. If so, the flowcontrol is directed to step 807. In step 807, console 10 reads thememory 400 of the hand piece 30 where the reprogram or upgrade code hasbeen stored in step 800. Using the reprogram or upgrade code read fromthe memory 400, the functions of console 10 are reprogrammed andupgraded. For example, if console 10 is experiencing operationaldifficulties with a specific generation or version of the hand piece, anupgrade from the memory 400 instructs console 10 to allow its use withonly newer versions or generations of the hand piece. The memory 400 canalso store information including the manufacture date, design revision,manufacturing code, lot code or other manufacture-related informationfor a specific grouping of hand pieces according to generation orversion having operational difficulties or defects, from which console10 can be reprogrammed or upgraded to refuse activation for use withsuch hand pieces.

In an alternative embodiment according to the invention, the reprogramcode can be stored in a non-volatile memory of a device other than thehand piece 30 with the memory 400. The non-hand piece device with thenon-volatile memory can be plugged directly into the electricalconnection 19 for upgrading or reprogramming console 10.

Moreover, the memory 400 can be utilized in adding an odometer functionto the generator console 10 by keeping track of the number of usesperformed for the hand piece 30 and/or the number of allowable usesremaining.

In addition to storing reprogram or upgrade code, the memory 400 canalso store performance criteria for operating the hand piece 30 withconsole 10. For example, the memory 400 can store energy levelinformation such as a maximum energy level for driving the particularhand piece 30, because, e.g., a relatively small hand piece may not beable to be driven, in terms of energy levels, as intensely as arelatively large hand piece for large-scale surgical procedures.Information correlating the energy levels for driving the hand piece 30and the corresponding output displacement can also be stored in thememory 400. The console 10 reads the energy level information stored inthe memory 400 and drives the hand piece 30 according to thecorresponding output displacement. In addition to energy levelinformation, driving signal characteristics, such as types of amplitudemodulation and resonance frequency, can be stored in the memory 400.Using the information stored in the memory 400, the console 10 and thehand piece 30 can perform the error prevention described herein withrespect to FIG. 6 and FIG. 7, and the reprogramming or upgrade ofconsole 10 described herein with respect to FIG. 8.

As described herein with respect to FIG. 2 and FIG. 3 and in the relatedU.S. application Ser. No. 09/693,621 incorporated herein by reference,the parts of the hand piece 30 in the operational mode are designed, asa whole, to oscillate at generally the same resonant frequency, wherethe elements of the hand piece 30 are tuned so that the resulting lengthof each such element is one-half wavelength. Microprocessor or DSP 60,using a phase correction algorithm, controls the frequency at which theparts of the hand piece 30 oscillate. Upon activation of the hand piece30, the oscillating frequency is set at a startup value or nominalresonant frequency such as 50 kHz which is stored in the memory 400 ofthe hand piece 30. A sweep of a frequency range between a start sweeppoint and a stop sweep point, whose values are also stored in the memory400, is effected under the control of the DSP 60 until the detection ofa change in impedance which indicates the approach to the resonantfrequency. Having obtained the resonant frequency, the parts of the handpiece 30 are caused to oscillate at that frequency.

FIG. 9 is a flow diagram that illustrates the operation of the handpiece 30 according to the invention at a resonant frequency usinginformation stored in the memory 400. Once the hand piece 30 isactivated (step 901), console 10 reads the memory 400 of the hand piece30 (step 903) and retrieves the information needed for operating thehand piece 30 at the resonant frequency, including the nominal resonantfrequency, a frequency range delimited by a start sweep point and a stopsweep point (step 905). A frequency sweep in that frequency range iseffected under the control of the DSP 60 (step 907). Detection of theresonant frequency is effected in step 909. If the resonant frequencyhas not yet been detected, the control flow reverts back to step 907where the frequency sweep is continued. Upon detection of the resonantfrequency, the control flow is directed to step 911 where the parts ofthe hand piece 30 are caused to oscillate at that resonant frequency.

FIG. 10 is a diagram that illustrates an alternative embodiment of theoperation of the hand piece 30 according to the invention at a resonantfrequency using information stored in the memory 400. Instead of storingthe start and stop sweep points of a frequency range for the frequencysweep, the memory 400 stores the nominal resonant frequency and a biasamount. The console 10 calculates the start and stop sweep points bysubtracting and adding the bias amount from the nominal resonantfrequency, respectively. A margin, which is a relatively small amountbeyond bias, is tacked on to the bias amount to respectively reach thestart and stop sweep points of the frequency range in which thefrequency sweep for seeking a resonant frequency is conducted. Once theresonant frequency is found, the parts of the hand piece 30 are causedto oscillate at that resonant frequency.

The memory 400 for an ultrasonic surgical hand piece 30 according to theinvention is located in the electrical connector which is disposedbetween the console 10 and the cable 26. The memory device 400 can alsobe located in one or more locations, including the electrical connector,within the housing of the hand piece 30, or at an in-line location inthe cable 26.

In addition to being an EEPROM, the memory 400 can be one or acombination of a Read Only Memory (ROM), Erasable Programmable Read OnlyMemory (EPROM), Random Access Memory (RAM) or any other volatile memorywhich is powered by a cell, battery, or capacitor, such as a supercapacitor. The memory 400 can also be a Programmable Array Logic (PAL),Programmable Logic Array (PLA), analog serial storage device, soundstorage integrated circuit or similar device, or a memory device inconjunction with a numeric manipulation device such as a microprocessorfor the purpose of encryption.

Although the invention has been particularly shown and described indetail with reference to the preferred embodiments thereof, theembodiments are not intended to be exhaustive or to limit the inventionto the precise forms disclosed herein. It will be understood by thoseskilled in the art that many modifications in form and detail may bemade therein without departing from the spirit and scope of theinvention. Similarly, any process steps described herein may beinterchangeable with other steps to achieve substantially the sameresult. All such modifications are intended to be encompassed within thescope of the invention, which is defined by the following claims andtheir equivalents.

1. A system for implementing surgical procedures comprising: anultrasonic surgical hand piece having an end-effector; a console havinga digital signal processor (DSP) for controlling the hand piece; anelectrical connection connecting the hand piece and the console, whereinthe console sends a drive current to drive the hand piece which impartsultrasonic longitudinal movement to the end-effector; and a memorydisposed in the electrical connection, wherein the console readsinformation stored in the memory to authenticate the hand piece for usewith the console.
 2. The system of claim 1 wherein the informationstored in the memory includes a cyclical redundancy check (CRC) code,and the information stored in the memory is in the form of a dataimplemented in firmware.
 3. The system of claim 1 wherein theinformation is an encrypted code, and the hand piece is authenticatedfor use with the console by decoding a corresponding encryptionalgorithm in the console and providing for a corresponding data pattern.4. The system of claim 1 wherein: the memory stores a handicap limit anda disable limit; the console instructs the hand piece to operate in ahandicap mode if the system exceeds the handicap limit, and the consoledisables the hand piece if the system exceeds the disable limit.
 5. Thesystem of claim 4 wherein handicap and disable limits relate totemperature and the handicap mode is appropriate for temperatureconditions.
 6. The system of claim 4 wherein the handicap limit and thedisable limit relate to the number of defective blades found in a timeperiod of operating the hand piece, and the handicap mode is appropriatefor the number of defective blade conditions.
 7. The system of claim 4wherein the handicap limit and the disable limit relate to the time thehand piece has been active, and the handicap mode is appropriate for thetime conditions.
 8. The system of claim 4 wherein the handicap limit andthe disable limit relate to the number of activations for the hand piecewithin a time period, and the handicap mode is appropriate for thenumber of activation conditions.
 9. The system of claim 4 wherein thehandicap mode involves one of operations below a certain speed orvibrational frequency, operating below a certain vibrationaldisplacement, and in a limited mode such as coagulation or cutting. 10.The system of claim 1 wherein the memory includes a reprogram code,wherein said DSP reads the reprogram code stored in the memory andalters at least one function of said console based on said reprogramcode.
 11. The system of claim 10 further comprising storage and upgradecode, whereon said DSP stores the storage and upgrade code which is readwith its operating program.
 12. The system of claim 11 wherein thereprogram code and the upgrade code are read from a non-volatile memoryof a non-hand piece device plugged into the electrical connection. 13.The system of claim 12 wherein said function of said console is adiagnostic hierarchy.
 14. The system of claim 12 wherein said functionof said console is a duty-cycle.
 15. The system of claim 12 wherein saidfunction of said console redefines power level settings.
 16. The systemof claim 12 wherein said function of said console redefines the consolefunction assigned to a switch.
 17. The system of claim 1 wherein theinformation stored in the memory correlates energy level information andcorresponding output displacement, wherein the console reads the energylevel information and drives the hand piece according to thecorresponding output displacement.
 18. The system of claim 1 wherein theinformation stored in the memory includes a start sweep point and a stopsweep point delimiting a frequency range, and wherein a frequency sweepis effected under control of the DSP in the frequency range loaded onthe nominal resonate frequency, the start and stop sweep points fordetecting a resonant frequency for operating the hand piece.
 19. Thesystem of claim 1 wherein the information stored in the memory includesa nominal resonant frequency, a bias amount and a margin amount fromwhich a frequency range is calculated, and wherein a frequency sweep iseffected under control of the DSP in the frequency range based on thenominal resonate frequency, bias current and margin current fordetecting a resonant frequency for operating the hand piece.
 20. Thesystem of claim 1 wherein the memory consists of at least one of anElectrically Erasable Programmable Read Only Memory (EEPROM), Read OnlyMemory (ROM), Erasable Programmable Read Only Memory (EPROM), RandomAccess Memory (RAM), Programmable Array Logic (PAL), Programmable LogicArray (PLA), analog serial storage device, sound storage integratedcircuit, a memory device in conjunction with a numeric manipulationdevice including a microprocessor for the purpose of encryption, andvolatile memory which is powered by a device consisting of a cell,battery and capacitor.
 21. The system of claim 1 wherein the memory isin a location consisting of one of the electrical connection, thehousing of the hand piece, and an in-line location in a cable connectingthe electrical connection with the console and the hand piece.
 22. Amethod for implementing surgical procedures in a system including anultrasonic surgical hand piece, a console having a microprocessor forcontrolling the hand piece, an electrical connection connecting the handpiece and the console, and a memory disposed in the electricalconnection, the method comprising the steps of: reading informationstored in the memory; determining whether particular data is present inthe memory; authenticating use of the hand piece with the console if theparticular data is present; and sending a drive current to drive thehand piece to impart ultrasonic movement to the blade.
 23. The method ofclaim 22 wherein the data is stored in memory in encrypted form furthercomprising the steps of: decoding the encrypted data with an encryptionalgorithm in the console; providing a corresponding-data pattern; andauthenticating the hand piece on the basis of the data pattern.
 24. Themethod of claim 22 further comprising the steps of: instructing the handpiece to operate in a handicap mode if temperature of the hand pieceexceeds a handicap limit; and disabling the hand piece if thetemperature of the hand piece exceeds a disable limit.
 25. The method ofclaim 22 further comprising the steps of: instructing the hand piece tooperate in a handicap mode if number of defective blades found in a timeperiod of operating the hand piece exceeds a handicap limit; anddisabling the hand piece if the number of defective blades found in thetime period exceeds a disable limit.
 26. The method of claim 22 furthercomprising the steps of: instructing the hand piece to operate in ahandicap mode if time the hand piece has been active exceeds a handicaplimit; and disabling the hand piece if the number of defective bladesfound in the time the hand piece has been active exceeds a disablelimit.
 27. The method of claim 22 further comprising the steps of:instructing the hand piece to operate in a handicap mode if number ofactivations for the hand piece within a time period exceeds a handicaplimit; and disabling the hand piece if the number of activations for thehand piece within the time period exceeds a disable limit.
 28. Themethod of claim 22 further comprising the step of re-initializing thehandicap limit and the disable limit based on varied operationalconditions of the hand piece.
 29. The method of claim 22 furthercomprising the steps of: determining whether a reprogram of the consoleis needed by reading an upgrade code stored in the memory; and reading areprogram code stored in the memory and reprogramming the console usingthe reprogram code, if it is determined that an upgrade of the consoleis needed.
 30. The method of claim 22 further comprising the steps of:reading energy level information stored in the memory; and driving thehand piece according to a corresponding output displacement; wherein theenergy level information stored in the memory is correlated withcorresponding output displacement for driving the hand piece.
 31. Themethod of claim 22 further comprising the steps of: reading a nominalresonant frequency, a start sweep point and a stop sweep pointdelimiting a frequency range from the memory; effecting a frequencysweep in the frequency range based on the reading; and detecting aresonant frequency for operating the hand piece.
 32. The method of claim22 further comprising the steps of: reading a nominal resonantfrequency, a bias amount and a margin amount from the memory;calculating a frequency range based on the nominal resonant frequency,the bias amount and the margin amount; effecting a frequency sweep inthe frequency range; and detecting a resonant frequency for operatingthe hand piece.
 33. The method of claim 22 further comprising the stepsof: keeping track of a number of uses for the hand piece; and keepingtrack of a number of remaining uses allowed for the hand piece.
 34. Themethod of claim 22 further comprising the steps of: providing an alertmode corresponding to the particular data; alerting conditions meetingcriteria for the alert mode.